An interventional study of SanaMente in Depression and/or Anxiety in the Mild-to-moderate Range, Stress (Psychology) and Chronic Medical Illness, sponsored by University of Colorado, Boulder. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Colorado, Boulder · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are:
This is a single-arm pilot study without comparison group.
Participants will:
This Stage IB feasibility and pilot study is designed to refine and evaluate the SanaMente program, a culturally tailored, peer-led intervention developed to address the intersecting mental and physical health needs of rural Latinx adults living with chronic medical conditions. The study will assess implementation processes and generate preliminary evidence to inform a future, fully powered efficacy trial.
The intervention will be delivered by bilingual peer mentors who will receive standardized training prior to facilitating small group sessions. Throughout the study, implementation outcomes-including recruitment, retention, attendance, intervention fidelity, and participant engagement-will be monitored to evaluate the practicality of delivering the program in rural community settings.
A mixed-methods evaluation will be used to examine both implementation and participant outcomes. Quantitative analyses will estimate changes in mental health symptoms, health behaviors, and overall well-being over the course of the intervention, with effect size estimates used to inform the design and sample size of future studies. Qualitative data collected from participant feedback will be analyzed to identify factors influencing program engagement, perceived benefits, barriers to participation, and recommendations for improving program content and delivery.
Study findings will be used to optimize the SanaMente intervention, enhance its cultural relevance and implementation strategies, and establish the feasibility of conducting a larger randomized controlled trial to evaluate its effectiveness.
Exclusion Criteria:
This is a single-arm, open-label study in which all participants receive the SanaMente intervention. Participants will be enrolled into peer-led groups of approximately 6-10 individuals and will complete the 6-8 week program.
Behavioral: SanaMente
SanaMente is a culturally responsive, peer-led behavioral program designed to support mental health and promote healthy lifestyle behaviors among rural Latino/a adults with chronic medical conditions and mental health concerns. The program is delivered by trained bilingual peer mentors in small group sessions over 6-8 weeks and integrates evidence-based strategies to improve depression, anxiety, stress, sleep, physical activity, nutrition, and overall well-being. The intervention emphasizes culturally relevant content, peer support, and skill-building to enhance self-management and emotional wellness.
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Change in total score from baseline to post-program will be evaluated.
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Change in total score from baseline to post-program will be evaluated.
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Body Weight
Body weight will be measured in kilograms (kg) using a calibrated digital scale following standardized clinical procedures. Change in body weight from baseline to post-program will be evaluated.
Time frame: Baseline and Post-Program (week6-8)
Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures. Change from baseline to post-program will be evaluated.
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures.
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Resting Heart Rate
Resting heart rate will be measured in beats per minute (bpm) using standardized clinical procedures.
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Glycemic control as assessed by Hemoglobin A1c (HbA1c)
HbA1c will be measured from a blood sample as an indicator of average blood glucose over the previous 2-3 months. Values are reported as percentage (%).
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Total Cholesterol
Fasting total cholesterol will be measured in mg/dL.
Time frame: Changes from baseline to post-program (week 6-8) will be evaluated.
LDL Cholesterol
Fasting low-density lipoprotein (LDL) cholesterol will be measured in mg/dL.
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
HDL Cholesterol
Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Triglycerides
Fasting triglycerides will be measured in mg/dL.
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT) will be assessed in fasting blood samples and reported in U/L. ALT is a marker of hepatocellular injury.
Time frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Electrolytes
Electrolyte balance will be assessed using serum sodium (mEq/L), potassium (mEq/L), and chloride (mEq/L), obtained from fasting blood samples. These measures reflect systemic fluid and electrolyte homeostasis.
Time frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Metabolic Function
Metabolic function will be assessed using fasting plasma glucose (mg/dL), obtained from fasting blood samples as an indicator of glycemic status..
Time frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) will be assessed in fasting blood samples and reported in U/L. AST is a marker of hepatocellular injury.
Time frame: Changes from Baseline to Post-program (week 6-8) will be evaluated
Total bilirubin
Total bilirubin will be assessed in fasting blood samples and reported in mg/dL. Total bilirubin is a marker of hepatic excretory function.
Time frame: Changes from Baseline to post-program (week 6-8) will be evaluated
Serum albumin
Serum albumin will be assessed in fasting blood samples and reported in g/dL. Serum albumin is a marker of hepatic synthetic function and nutritional status.
Time frame: Changes from Baseline to post-program (week 6-8) will be evaluated
Serum creatinine
Serum creatinine will be assessed in fasting blood samples and reported in mg/dL. Serum creatinine is a marker of glomerular filtration and renal function.
Time frame: Changes from Baseline to post-program (week 6-8) will be evaluated
Blood urea nitrogen (BUN)
Blood urea nitrogen (BUN) will be assessed in fasting blood samples and reported in mg/dL. BUN is a marker of renal function and protein metabolism.
Time frame: Changes from Baseline to post-program (weeks 6-8) will be evaluated
Perceived stress as assessed by the Perceived Stress Scale (PSS-10)
Perceived Stress Scale-10 (PSS-10). The PSS-10 is a 10-item self-report measure that assesses the degree to which situations in one's life are appraised as stressful during the past month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. Change in total PSS-10 score from baseline to post-program will be evaluated.
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Behavioral activation as assessed by the Behavioral Activation for Depression Scale-Short Form (BADS-SF)
Behavioral Activation for Depression Scale-Short Form (BADS-SF). The BADS-SF is a self-report measure of behavioral activation and avoidance associated with depression. Total scores range from 0 to 54, with higher scores indicating greater behavioral activation. Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Disability and functioning as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; 12-item, self-administered version). The WHODAS 2.0 is a 12-item self-report measure assessing disability and functioning across six domains of daily life. Total scores range from 0 to 48 using simple scoring, with higher scores indicating greater disability. Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
International Physical Activity Questionnaire (IPAQ; Short Form). The IPAQ is a validated self-report instrument designed to assess health-related physical activity across countries. The short form includes 4 items assessing frequency and duration of vigorous activity, moderate activity, walking, and sitting during the last 7 days. Physical activity will be summarized as total metabolic equivalent (MET)-minutes per week. Higher values indicate greater physical activity.
Time frame: Baseline, mid program (week 3-4), post-program (week 6-8)
Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ)
Dietary Screener Questionnaire (DSQ). The DSQ is a self-report instrument developed to assess dietary intake patterns over the past 30 days, including frequency of consumption of fruits, vegetables, fiber, whole grains, dairy, added sugars, and other dietary components. The DSQ is used to estimate intake of specific food groups rather than generate a single total score. Higher estimated values indicate greater consumption of the respective dietary components being assessed.
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS)
Everyday Discrimination Scale (EDS). The EDS is a self-report measure assessing the frequency of routine experiences of unfair treatment and discrimination in daily life. The standard scale includes multiple items rated on a Likert-type frequency scale, with response options typically ranging from "never" to "almost every day." Total scores are calculated by summing item responses, with higher scores indicating greater perceived discrimination.
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)
Participant satisfaction with the SanaMente program will be assessed using the Client Satisfaction Questionnaire (CSQ-8). Higher scores indicate greater satisfaction with the program and services received.
Time frame: Post-program (weeks 6-8)
Program usability and acceptability
Participants will complete an investigator-developed exit survey assessing the program's usability, cultural relevance, perceived impact, and recommendations for improvement.
Time frame: Post-program (week 6-8)
Participant demographic Characteristics
Demographic information, including age, sex, gender identity, education, country of origin, language preference, employment status, and other background characteristics, will be collected to describe the study population and explore associations with study outcomes.
Time frame: baseline
Suicide risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Screener
Suicide risk will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) Screener to identify suicidal ideation and behaviors and facilitate appropriate safety referrals when indicated. This is a safety assessment and not an efficacy outcome.
Time frame: As clinically indicated throughout study participation (baseline, mid-program week 3-4, and post-program week 6-8)
Alcohol Use Disorders Identification Test (AUDIT)
Alcohol use will be assessed among participants who endorse current alcohol use using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a validated 10-item self-report questionnaire that assesses hazardous and harmful alcohol consumption and alcohol-related problems.
Time frame: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Drug Use Disorders Identification Test (DUDIT)
Drug use will be assessed among participants who endorse current drug use using the Drug Use Disorders Identification Test (DUDIT). The DUDIT is a validated self-report questionnaire that assesses the frequency and severity of drug use and drug-related problems.
Time frame: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Fagerström Test for Nicotine Dependence (FTND)
Nicotine dependence will be assessed among participants who endorse current tobacco or nicotine use using the Fagerström Test for Nicotine Dependence (FTND). The FTND is a validated self-report questionnaire that assesses the severity of nicotine dependence.
Time frame: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
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University of Colorado, Boulder